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The study will observe and quantify shifts in colposcopy practice and outcome improvements in U.S. community-based cervical screening colposcopy examinations after the introduction of the DySIS colposcope with Advanced Cervical Scan.

The study will collect colposcopy data across multiple sites in two arms; a prospective arm, with DySIS being used for the examination and a retrospective arm, with data retrieved from patient charts.

Condition or disease

Intervention/treatment

High Grade Cervical Intraepithelial Neoplasia

Device: DySIS

Detailed Description:

Each site will contribute data to both arms; the study will collect data on demographics, disease yield, number of biopsies and treatment decisions. Study subjects will receive standard of care procedures and management.

Prospective data will be collected at colposcopy examinations performed using the DySIS digital colposcope on consecutive patients that have been referred for colposcopy after a positive screening test. Retrospective data on colposcopy examinations performed using a standard colposcope will be collected from patient medical records, to capture standard practice to-date as a control for comparisons. The retrospective data will be collected from consecutive examinations performed by the providers participating in the prospective arm and for the preceding year.

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Ages Eligible for Study:

21 Years and older (Adult, Senior)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population

Women referred for colposcopy after an abnormal screening test for prevention of cervical cancer

Criteria

Inclusion Criteria:

Females 21 years or older

Able to give informed consent

Referred for colposcopy with a screening test result that indicates the need for a colposcopy, based on guidelines and practice: